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As 3D printing becomes cheaper and more reliable, the ability to circumvent traditional manufacturing is problematic for patents rights holders.

Since 2006, Align (the inventors of Invisaline) have been trying to prevent competitor ClearCorrect from producing a similar product.

Align own seven US patents directed towards methods for producing orthodontic teeth aligners using digital models of patients' teeth. Align produce the orthodontic teeth aligners using 3D printers. In an attempt to bypass Align’s US patents, ClearCorrect US creates a digital file of a patient’s teeth in the US and then sends the file over the Internet to ClearCorrect in Pakistan, who process the files and create a set of files that correspond to successive tooth arrangements. ClearCorrect Pakistan then send the files over the internet to ClearCorrect in the US, who print the aligners using 3D printers.

In 2014, Align successfully convinced the International Trade Commission (ITC) to issue cease and desist orders against ClearCorrect US and ClearCorrect Pakistan. The ITC can issues orders that prevent the importation, sale for importation, or sale within the United States after importation, of “articles that infringe” a valid and enforceable U.S. patent. ClearCorrect appealed this decision to the U.S. Court of Appeals for the Federal Circuit, alleging that digital files are not “articles” per se, and thus do not fall within the scope of 19 USC § 1337.

On 10 November 2015, the U.S. Court of Appeals for the Federal Circuit found that the ITC does not have authority to prevent the importation of digital files over the Internet, as the files are intangible objects, and thus not “articles” that fall within the scope of 19 USC § 1337. An extension to this decision may be that 3D printable digital blueprints are not “articles of manufacture”, and are thus not patent eligible subject matter in the US.

This decision will have huge ramifications for US patent law and the manufacturing industry generally, where 3D printing is on the rise. Recently, the FDA approved Aprecia Pharmaceuticals’ 3D printed drug Spritam. If a doctor were to source a 3D printer and the requisite material, the doctor would then be able to print an unauthorised Spritam-like drug on the spot to administer to a patient. In this situation, the doctor may very well be the infringer of any patent rights that Aprecia Pharmaceuticals own for the product. Obviously, this is far from an ideal situation, as Aprecia does not want to sue potential customers. Importantly, following the recent decision of the Federal Circuit, Aprecia Pharmaceuticals would not be able to prevent an overseas company from providing the doctor with the 3D printable digital blueprints for the drug under US patent law.

As 3D printing becomes cheaper and more reliable, consumers will be able to fabricate many articles at home, by-passing the need for traditional mass manufacturing. If patent owners are not able to assert patents for 3D printable digital blueprints, patent owners may be forced to target individual consumers. Unless you are an advocate of open source technology, this is far from an ideal situation, including for the patent rights holder, who has usually invested many years and $ into its R&D. The ability to circumvent traditional manufacturing and the effect on IP law is problematic. We will be keeping a close eye on developments in the US, as many of our clients have patents and conduct business in the US and, more recently, US judicial developments have had a flow-on effect to Australia.

If you have any further questions or require expert advice, please don't hesitate to contact us.  

Author: Gus Lightowlers

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